Vascular puncture seal anchor nest

ABSTRACT

The present invention provides a method and apparatus for sealing a subcutaneous tissue puncture. The method and apparatus increases the reliability of device function by creating a multi-level anchor nest in a carrier tube of a tissue puncture closure device. The multi-level nest allows an insertion sheath or other deployment member to slide between the carrier tube and the anchor to rotate and deploy the anchor within an artery or other lumen.

FIELD OF THE INVENTION

The present invention relates to medical devices, and, moreparticularly, to a vascular puncture sealing apparatus with nestfeatures to aid in anchor function.

BACKGROUND OF THE INVENTION

Various medical procedures, particularly cardiology procedures, involveaccessing a corporeal vessel or other lumen through a percutaneoussheath. Insertion of the sheath necessarily requires a hole or openingin the vessel wall so that a medical procedure can be performed throughthe sheath. After the particular medical procedure has been performed,the sheath must eventually be removed from the vessel and the accesshole in the vessel wall must be closed.

A number of prior vascular closure devices have been developed to closethe hole or puncture in the vessel wall. Closing the hole typicallyinvolves packing a resorbable sealing plug at the hole or sandwichingthe hole between the sealing plug and an anchor. Examples of priorvascular closure devices are described in U.S. Pat. Nos. 6,179,863;6,090,130; and 6,045,569 and related patents that are herebyincorporated by reference.

Placing the sealing plug often comprises several steps. First, apuncture site is located. A puncture locator is placed in and throughthe insertion sheath such that an inlet port in the puncture locatorresides outside a distal end of the insertion sheath a predetermineddistance. The insertion sheath and puncture locator are inserted throughthe puncture into a blood vessel. As the distal end of the puncturelocator penetrates the blood vessel, blood flows into the inlet port andout of a drip hole via a flow path through the puncture locator.

Blood exiting the drip hole indicates that the puncture locator andinsertion sheath have just penetrated the blood vessel. To ensure properplacement of the insertion sheath and subsequently the closure device,the insertion sheath and puncture locator are normally backed out of thevessel until blood stops flowing from the drip hole. Next, the insertionsheath and puncture locator are re-inserted into the blood vessel untilblood starts flowing again from the drip hole. Proper depth ofpenetration and location of the assembly is established by continuing toinsert an additional predetermined distance, for example, an operatoroften inserts the assembly 1 to 2 centimeters further if the bloodvessel is a femoral artery. Once the insertion sheath is properlylocated, the puncture locator is removed and the vascular closure devicemay be inserted through the sheath and into to the blood vessel.

An anchor at a distal end of the vascular closure device is thendeployed within the artery. The anchor is initially aligned with alongitudinal axis of the closure device in a covered nest of the closuredevice. The anchor is deployed by removing a cover from the anchor andinserting the anchor through the insertion sheath, which allows theanchor to rotate and align itself with an interior wall of the bloodvessel. However, sometimes when the anchor is deployed, it tends toremain in or reenter the sheath instead of rotating and aligning withthe blood vessel. This phenomenon is termed “shuttling.” Shuttlingdisables the function, and negates the benefit, of the device.Therefore, it is desirable to have an apparatus that reduces oreliminates anchor shuttle so that the closure device will function asexpected.

SUMMARY OF THE INVENTION

In one of many possible embodiments, the present invention provides atissue puncture closure assembly comprising a closure device for partialinsertion into and sealing of an internal tissue wall puncture. Theclosure device includes a filament extending from a first end of theclosure device, a nest comprising a first surface, an anchor forinsertion through the tissue wall puncture seated in the nest andattached to the filament at the first end of the closure device, asealing plug slidingly attached to the filament adjacent to the anchor,and a gap between the nest and a portion of the anchor. The nest mayinclude a second surface spaced from a first surface of the anchor, thespacing between the first surface of the anchor and the second surfaceof the nest defining the gap. The first and second nest surfaces may beapproximately parallel to one another. The nest may also include a thirdsurface, where the first, second and third nest surfaces are compressedto different depths. The assembly may also include an insertion sheaththat has a first end and is receptive of the closure device. The firstend of the insertion sheath may include a monofold that fits in the gapbetween the nest and the anchor upon distal movement of the insertionsheath relative to the closure device. Alternatively, the anchor mayinclude an indentation spaced from the first surface of the nest, thespacing between the indentation in the anchor and the first surface ofthe nest defining the gap.

In another embodiment the invention provides a tissue puncture closureassembly comprising another closure device for partial insertion intoand sealing of an internal tissue wall puncture. The closure deviceincludes a carrier tube having a split-level nest at a distal end, afilament extending through the carrier tube, and an anchor attached tothe filament at the distal end of the carrier tube and seated in thesplit-level nest. The closure device may further include a sealing plugdisposed inside the distal end of the carrier tube. The sealing plug isslidingly attached to the filament. The split-level nest may include afirst nest surface adjacent to a first surface of the anchor, and asecond nest surface spaced from the first surface of the anchor. Thesplit-level nest may be a tri-level nest.

Another embodiment of the invention provides a tissue puncture closuredevice, the tissue puncture closure device comprising a carrier tubehaving a distal end, a sealing plug disposed inside the distal end ofthe carrier tube, a multi-level compression zone or area disposed in thedistal end of the carrier, and an anchor seated in the multi-levelcompression area of the carrier. The multi-level compression areacomprises a first compression zone at a first depth, and a secondcompression zone at a second depth, such that the anchor bears againstthe first compression zone and a first gap is formed between the anchorand the second compression zone. The multi-level compression zone mayinclude a third compression zone at a third depth, such that a secondgap larger than the first gap is formed between the anchor and the thirdcompression zone.

Another embodiment of the invention provides a tissue puncture closuredevice assembly including a carrier tube having a distal end and afilament extending therethrough, a sealing plug disposed inside thedistal end of the carrier tube and attached to the filament, an anchorattached to the filament at the distal end of the carrier tube, and amulti-level die for compressing a multi-level nest in the distal end ofthe carrier tube. The multi-level die includes a first level and asecond level, the second level being higher than the first level. Themulti-level die may include a third level, the third level being higherthan the first and second levels.

Another aspect of invention provides a method of making a tissuepuncture closure device including providing a carrier tube, threading asuture through the carrier tube, threading the suture through a sealingplug and an anchor, and crushing a multi-level nest into a distal end ofthe carrier tube. The method may also include nesting the anchor in themulti-level nest. The nesting may further comprise leaving a gap betweena portion of the anchor and one level of the multi-level nest. Thecompression of the carrier tube may include engaging a multi-level diewith the distal end of the carrier tube. The multi-level nest mayinclude two or more different levels.

Another aspect of the invention provides a method of sealing a tissuepuncture in an internal tissue wall accessible through a percutaneousincision. The method includes providing a tissue puncture closure devicecomprising a carrier tube with a filament extending therethrough. Thefilament is connected at a distal end of the carrier tube to an anchor,and the anchor is seated in a multi-level nest disposed in the carriertube. The filament is also connected to a sealing plug located proximalof the anchor for disposition and anchoring about the tissue puncture.The method also includes inserting the tissue puncture closure deviceinto the percutaneous incision, deploying the anchor into the tissuepuncture, withdrawing the closure device from the percutaneous incision,and tamping the sealing plug toward the anchor. The step of deployingthe anchor may further comprise sliding a formed monofold tip of aninsertion sheath into a gap formed between the anchor and themulti-level nest disposed in the carrier tube.

Another aspect of the invention provides a method of reducing anchorshuttle in a subcutaneous tissue puncture sealing device comprisingproviding a gap between a carrier tube of the tissue puncture sealingdevice and the anchor by creating a multi-level nest in the carriertube, where the anchor initially seats in the multi-level nest.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings illustrate various embodiments of the presentinvention and are a part of the specification. The illustratedembodiments are merely examples of the present invention and do notlimit the scope of the invention.

FIG. 1A is a cut-away view of a tissue puncture closure device accordingto the prior art.

FIG. 1B is a detail of the cut-away section of FIG. 1A.

FIG. 2A is a top view of the tissue puncture closure device of FIG. 1Aengaged with an insertion sheath in a first position according to theprior art.

FIG. 2B is a detailed cross-sectional view of the tissue punctureclosure device and insertion sheath of FIG. 2A.

FIG. 3 is a cross-sectional view of the tissue puncture closure deviceof FIG. 1A in relation to the insertion sheath of FIG. 2A in a secondposition according to the prior art.

FIG. 4 is a cross-sectional view of the tissue puncture closure devicesof FIG. 1A in relation to the insertion sheath of FIG. 2A in a thirdposition according to the prior art.

FIG. 5 is a perspective view of the tissue puncture closure device ofFIG. 1A and insertion sheath of FIG. 2A shown in relation to a patientwith an anchor deployed according to the prior art.

FIG. 6 is a cross-sectional view of the tissue puncture closure deviceof FIG. 1A in relation to the insertion sheath of FIG. 2A in a fourthposition illustrating shuttling according to the prior art.

FIG. 7 is a cross-sectional view of a tissue puncture closure deviceaccording to one embodiment of the present invention.

FIG. 8 is a cross-sectional view of the tissue puncture closure deviceof FIG. 7 shown in relation to an insertion sheath in a first positionaccording to one embodiment of the present invention.

FIG. 9 is a cross-sectional view of the tissue puncture closure deviceof FIG. 7 shown in relation to the insertion sheath of FIG. 8 in asecond position according to one embodiment of the present invention.

FIG. 10 is a cross-sectional view of the tissue puncture closure deviceof FIG. 7 shown in relation to the insertion sheath of FIG. 8 in a thirdposition according to one embodiment of the present invention.

FIG. 11 is a cross-sectional view of the tissue puncture closure deviceof FIG. 7 shown in relation to the insertion sheath of FIG. 8 in afourth position according to one embodiment of the present invention.

FIG. 12 is a side view of a die component of a tissue puncture closureassembly according to one embodiment of the present invention.

FIG. 13 is a cross-sectional view of a tissue puncture closure deviceaccording to another embodiment of the present invention.

FIG. 14 is a side view of another die component of a tissue punctureclosure assembly according to one embodiment of the present invention.

FIG. 15 is a perspective view of the tissue puncture closure device ofFIGS. 7 or 13 and the insertion sheath of FIG. 8 shown in relation to apatient with an anchor deployed according to the present invention.

FIG. 16 is a perspective view according to FIG. 15 with an operatortamping a sealing plug according to the present invention.

Throughout the drawings, identical reference numbers designate similar,but not necessarily identical elements.

DETAILED DESCRIPTION

As mentioned above, vascular procedures are commonly performedthroughout the world and require access to a lumen through a puncture.Most often, the lumen is a femoral artery. To close the puncture, manytimes a closure device is used to sandwich the puncture between ananchor and a sealing plug. However, there exists a possibility for theanchor to not deploy, disabling the function and negating the benefit ofthe device. The present invention describes methods and apparatus toreduce or eliminate non-deployment or “shuttle” of a closure deviceanchor. While the vascular instruments shown and described below includeinsertion sheaths and puncture sealing devices, the application ofprinciples described herein to reduce anchor shuttle is not limited tothe specific devices shown. The principles described herein may be usedto reduce anchor shuttle for any vascular closure device. Therefore,while the description below is directed primarily to arterial proceduresand certain embodiments of a vascular closure device, the methods andapparatus are only limited by the appended claims.

As used throughout the claims and specification the term “monofold” isused broadly to encompass any plastic deformation of a tube tip,especially a plastically deformed tube tip that forms a one-way valvewith respect to an anchor. The term “approximately” or “substantially”means within ten percent of a given measurement or property. A “lumen”refers to any open space or cavity in a bodily organ, especially in ablood vessel. The words “including” and “having,” as used in thespecification, including the claims, have the same meaning as the word“comprising.”

Referring now to the drawings, and in particular to FIGS. 1A-1B, avascular puncture closure device 100 is shown according to the priorart. The vascular puncture closure device 100 includes a carrier tube102 with a filament or suture 104 extending at least partiallytherethrough. External to the first or distal end 106 of the carriertube is an anchor 108. The anchor is an elongated, stiff, low profilemember including an eye 109 formed at the middle. The anchor 108 istypically made of a biologically resorbable polymer.

The suture 104 is treaded through the anchor 108 and back to a collagensponge 110. The collagen sponge 110 is slidingly attached to the suture104 as the suture passes distally through the carrier tube 102, but asthe suture traverses the anchor 108 and reenters the carrier tube 102,it is securely slip knotted proximal to the collagen sponge 110 tofacilitate cinching of the collagen sponge 110 when the closure device100 is properly placed and the anchor 108 deployed (see FIG. 5).

The carrier tube includes a tamping tube 112 disposed therein. Thetamping tube 112 is slidingly mounted on the suture 104 and may be usedby an operator to tamp the collagen sponge 110 toward the anchor 108 atan appropriate time to plug a percutaneous tissue puncture.

At the distal end 106 of the carrier tube 102 is a nest 114. Prior todeployment of the anchor 108 within an artery, the eye 109 rests outsidethe distal end 106 of the carrier tube 102, and one end 116 of theanchor 108 rests in the nest 114. The nest 114 is typically compressedor crushed to a depth such that a second surface 118 of the anchor 108is flush with the outer diameter of the carrier tube 102. The nest 114is compressed to a length that is longer than the end 116 of the anchor108. The anchor 108 may be temporarily held in place in the nest 114 bya bypass tube 117 disposed over the distal end 106 of the carrier tube102.

The flush arrangement of the anchor 108 and carrier tube 102 allows theanchor to be inserted into an insertion sheath 220 as shown in FIG.2A-2B, and eventually through an arterial puncture 501 (shown in FIG.5). However, the bypass tube 117 includes an oversized head 119 thatprevents the bypass tube 117 from passing through an internal passage221 of the insertion sheath 220. Therefore, as the puncture closuredevice 100 is inserted into the internal passage 221 of the insertionsheath 220, the oversized head 119 bears against a surface 223 ofinsertion sheath. Further insertion of the puncture closure device 100results in sliding movement between the carrier tube 102 and the bypasstube 117, releasing the anchor 108 from the bypass tube 117. However,the anchor 108 remains in the nest 114 following release from the bypasstube 117, limited in movement by the insertion sheath 220.

The insertion sheath 220 includes a first end 222 having a monofold 224.The monofold 224 acts as a one-way valve to the anchor 108. As shown inFIG. 2A-2B and 3, the monofold 224 is a plastic deformation in a portionof the insertion sheath 220 that elastically flexes as the anchor 108 ispushed out through the first end 222 of the insertion sheath 220.However, as the anchor 108 passes though and out of the first end 222 ofthe insertion sheath 220 as shown in FIG. 3, the monofold 224 attemptsto spring back to its original deformed position and a biased tip 226 ofthe monofold 224 engages the nest 114. As relative movement between thecarrier tube 102 and the insertion sheath 220 continues, the biased tip226 traverses the contour 128 of the carrier tube nest 114 in a proximaldirection.

Typically, after the anchor 108 passes through the first end 222 of theinsertion sheath 220 and enters an artery 530 (FIG. 5), the punctureclosure device 100 is pulled in a proximal direction with respect to theinsertion sheath 220. The biased tip 226 of the monofold 224 thusfollows the contour 128 and usually slides distally between the anchor108 and the nest 114, causing the anchor to rotate as shown in FIG. 4.Accordingly, if all goes well, the anchor 108 is deployed within theartery as shown in FIG. 5 and does not reenter the insertion sheath 220.

However, because the end 116 of the anchor 108 normally bears directlyagainst the nest 114, sometimes the biased tip 226 of the monofold 224slides over the anchor 108 as shown in FIG. 6 when the closure device100 is pulled proximally with respect to the insertion sheath 220instead of sliding between the end 116 and nest 114. Thus, rather thandeploying properly within the artery, the anchor 108 is sometimesreinserted into the insertion sheath 220, and the puncture closuredevice 100 fails.

Therefore, according to some embodiments of the present invention, atissue closure device 700 includes a modified carrier tube 702 as shownin FIG. 7. The modified carrier tube 702 includes a split-level ormulti-level nest 714 at the first or distal end 706. When the anchor isseated in a first or insertion position as shown, the multi-level nest714 of FIG. 7 includes a first surface 732 that is adjacent to a firstsurface 734 of the anchor 108. However, the multi-level nest alsoincludes a second surface 736 that is spaced from the first surface ofthe anchor 108, creating a gap 738 between a portion of the end 116 ofthe anchor 108 and the second surface 736 of the nest 714. The first andsecond surfaces 732, 736 are substantially parallel to one another asshown, but this is not necessarily so.

Referring next to FIGS. 8-9, a tissue closure assembly 800 includes thetissue closure device 700 and the insertion sheath 220. As the closuredevice 700 is inserted through the insertion sheath 220, the anchor 108impinges and deforms the monofold 224 in a manner similar to thatdescribed above with reference to FIG. 3. However, as the anchor passesout of the insertion sheath 220 as shown in FIG. 10, the monofold 224springs back and impinges on the second surface 736 spaced from thefirst surface 734 of the anchor 108 instead of the first surface 732that the anchor 108 bears against. Accordingly, as the tissue closuredevice 700 is pulled back into the insertion sheath 220, the tip 226 ofthe monofold slips easily into the gap 738, advantageously reducing oreliminating any possibility of the anchor 108 sliding back into theinsertion sheath 220. Therefore, as the closure device 700 is pulledproximally with respect to the insertion sheath 220, the anchor rotatesand deploys as shown in FIG. 11.

The multi-level nest 714 may be created, for example, by heating and/orcompressing or crushing the first end 706 of the carrier tube 702 with adie, such as the anvil 1240 shown in FIG. 12. Therefore, the anvil 1240may also be part of the tissue closure assembly 800. The anvil 1240 ismade of structural materials such as steel and may include a first level1242 and a second level 1244. According to the embodiment of FIG. 12,the second level 1244 is higher than the first level 1242 by apredetermined distance D1. D1 may range between approximately 0.01 and0.030 inches, preferably about 0.020 inches. The first and second levels1242, 1244 are each higher than a main level 1246 and correspond tocompression zones in the carrier tube 702 (FIG. 7) that result in thefirst and second surfaces 732, 736 (FIG. 7) of the nest 714 (FIG. 7).The second level 1244 is higher than the main level 1246. Normally, themain level 1246 does not crush or impinge on the carrier tub 702 (FIG.7), but instead limits the compression caused by the first and secondlevels 1242, 1244. The first level 1242 is offset from the second level1244 by a second distance D2. D2 may range between approximately 0.030and 0.080 inches, preferably about 0.055 inches. Other methods ofcreating the nest 714 (FIG. 7) may also be used.

The present invention is not limited to the split-level configurationfor the nest 714 as shown in FIG. 7. For example, according to FIG. 13there is another tissue puncture closure device 1300 shown. The tissuepuncture closure device 1300 includes a carrier tube 1302 with amulti-level nest 1314 comprising three spaced surfaces 1332, 1336, 1337,respectively, that are generally parallel with one another. The threespaced surfaces 1332, 1336, 1337 create a tiered gap 1338 may includefirst and second gaps 1339 and 1341, and may even further ensure thatthe monofold 224 (FIG. 2B) or other one-way valve will not allow theanchor 108 to reenter the insertion sheath 220 (FIG. 2B) once it haspassed therethrough. Other multi-level nests may also be used to createmore than three surfaces, if desired.

The multi-level nest 1314 may be formed by heating and/or compressingthe carrier tube (not shown in FIG. 13) with a die, such as the anvil1440 shown in FIG. 14. Therefore, the anvil 1440 may also be part of thetissue closure assembly 800 (FIG. 15). According to the embodiment ofFIG. 14, the anvil 1440 includes a first level 1442, a second level1444, and a third level 1445. The second level 1444 is higher than thefirst level 1442, and the third level 1445 is higher than the secondlevel 1444. All three levels 1442, 1444, 1445 are higher than a mainlevel 1446 and correspond to the first, second and third surfaces orcompression zones 1332, 1336, 1337, respectively, of the carrier tube(not shown in FIG. 13).

The embodiments shown in FIGS. 8 and 13 may include similar or identicalelements shown in FIGS. 1-2. For example, referring to FIG. 15, theclosure device 800 (and 1300 in FIG. 13) may include the suture 104 (orother filament) extending from the first end 106 of the closure device800, a sealing plug such as the collagen sponge 110 slidingly attachedto the suture 104 and the tamping tube 112. FIG. 15 shows the closuredevice 800 inserted partially through a puncture 162 in an artery 160,with the anchor 108 and the collagen sponge 110 deployed.

Referring to FIGS. 15-16, a method of sealing the puncture 160 accordingto the present invention may include inserting the tissue punctureclosure device 800 into a percutaneous incision 164 and deploying theanchor 108 into the tissue puncture 162 as shown in FIG. 15. The methodmay also include withdrawing the closure device 800 from thepercutaneous incision 164 and tamping the sealing plug 110 toward theanchor 108 with the tamping tube 112. The step of deploying the anchormay further comprise sliding the monofold tip 226 (FIGS. 3-4) of theinsertion sheath 220 into the gap 738 (FIG. 7) formed between the anchor108 and the multi-level nest 714 (FIG. 7) disposed in the carrier tube702.

While the invention has been particularly shown and described withreference to embodiments thereof, it will be understood by those skilledin the art that various other changes in the form and details may bemade without departing from the scope of the invention.

1. A tissue puncture closure assembly comprising a closure device forpartial insertion into and sealing of an internal tissue wall puncture,the closure device comprising: a filament extending from a first end ofthe closure device; a nest comprising a first surface; an anchor forinsertion through the tissue wall puncture seated in the nest andattached to the filament at the first end of the closure device; theanchor having a first surface; a sealing plug slidingly attached to thefilament adjacent to the anchor; a gap between the nest and a portion ofthe anchor.
 2. A tissue puncture closure assembly comprising a closuredevice for partial insertion into and sealing of an internal tissue wallpuncture according to claim 1 wherein the nest further comprises asecond surface spaced from the first surface of the anchor, the spacingbetween the first surface of the anchor and the second surface of thenest defining the gap.
 3. A tissue puncture closure assembly comprisinga closure device for partial insertion into and sealing of an internaltissue wall puncture according to claim 2 wherein the first and secondnest surfaces are approximately parallel to one another.
 4. A tissuepuncture closure assembly comprising a closure device for partialinsertion into and sealing of an internal tissue wall puncture accordingto claim 2, further comprising a carrier tube, wherein the first nestsurface comprises a first portion of the carrier tube compressed to afirst depth, and the second nest surface comprises a second portion ofthe carrier tube compressed to a second depth.
 5. A tissue punctureclosure assembly comprising a closure device for partial insertion intoand sealing of an internal tissue wall puncture according to claim 4wherein the second depth is deeper than the first depth.
 6. A tissuepuncture closure assembly comprising a closure device for partialinsertion into and sealing of an internal tissue wall puncture accordingto claim 4, further comprising a third nest surface, wherein the thirdnest surface comprises a third portion of the carrier tube compressed toa third depth.
 7. A tissue puncture closure assembly comprising aclosure device for partial insertion into and sealing of an internaltissue wall puncture according to claim 6 wherein the third depth isdeeper than the second depth.
 8. A tissue puncture closure assemblycomprising a closure device for partial insertion into and sealing of aninternal tissue wall puncture according to claim 1, further comprisingan insertion sheath receptive of the closure device and having a firstend.
 9. A tissue puncture closure assembly comprising a closure devicefor partial insertion into and sealing of an internal tissue wallpuncture according to claim 8 wherein the first end comprises amonofold.
 10. A tissue puncture closure assembly comprising a closuredevice for partial insertion into and sealing of an internal tissue wallpuncture according to claim 9 wherein the monofold fits in the gapbetween the nest and the anchor upon distal movement of the insertionsheath relative to the closure device.
 11. A tissue puncture closureassembly comprising a closure device for partial insertion into andsealing of an internal tissue wall puncture according to claim 1,further comprising a bypass tube initially disposed about the anchor totemporarily hold the anchor in the nest.
 12. A tissue puncture closureassembly comprising a closure device for partial insertion into andsealing of an internal tissue wall puncture, the closure devicecomprising: a carrier tube having a split-level nest at a distal end; afilament extending at least partially through the carrier tube; ananchor attached to the filament at the distal end of the carrier tubeand seated in the split-level nest.
 13. A tissue puncture closureassembly comprising a closure device for partial insertion into andsealing of an internal tissue wall puncture according to claim 12,further comprising a sealing plug disposed inside the distal end of thecarrier tube.
 14. A tissue puncture closure assembly comprising aclosure device for partial insertion into and sealing of an internaltissue wall puncture according to claim 13 wherein the sealing plug isslidingly attached to the filament.
 15. A tissue puncture closureassembly comprising a closure device for partial insertion into andsealing of an internal tissue wall puncture according to claim 12wherein the split-level nest comprises a first nest surface adjacent toa first surface of the anchor, and a second nest surface spaced from thefirst surface of the anchor.
 16. A tissue puncture closure assemblycomprising a closure device for partial insertion into and sealing of aninternal tissue wall puncture according to claim 15 wherein the spacingbetween the first surface of the anchor and the second surface of thesplit-level nest defines a gap between the split-level nest and theanchor.
 17. A tissue puncture closure assembly comprising a closuredevice for partial insertion into and sealing of an internal tissue wallpuncture according to claim 16, further comprising an insertion sheathreceptive of the closure device and having a first end.
 18. A tissuepuncture closure assembly comprising a closure device for partialinsertion into and sealing of an internal tissue wall puncture accordingto claim 17 wherein the first end comprises a monofold in the insertionsheath.
 19. A tissue puncture closure assembly comprising a closuredevice for partial insertion into and sealing of an internal tissue wallpuncture according to claim 18 wherein the monofold fits in the gapbetween the first and second surfaces of the split-level nest upondistal movement of the insertion sheath relative to the closure device.20. A tissue puncture closure assembly comprising a closure device forpartial insertion into and sealing of an internal tissue wall punctureaccording to claim 12 wherein the split-level nest comprises a firstportion of the carrier tube compressed to a first depth, and the secondnest surface comprises a second portion of the carrier tube compressedto a second depth.
 21. A tissue puncture closure assembly comprising aclosure device for partial insertion into and sealing of an internaltissue wall puncture according to claim 12, wherein the split-level nestfurther comprises a tri-level nest.
 22. A tissue puncture closuredevice, comprising: a carrier tube having a distal end; a sealing plugdisposed inside the distal end of the carrier tube; a multi-levelcompression zone disposed in the distal end of the carrier; an anchorseated in the multi-level compression zone of the carrier.
 23. A tissuepuncture closure device according to claim 22 wherein the multi-levelcompression zone comprises a first compression zone at a first depth anda second compression zone at a second depth, wherein the anchor bearsagainst the first compression zone and a first gap is formed between theanchor and the second compression zone.
 24. A tissue puncture closuredevice according to claim 23 wherein the multi-level compression zonefurther comprises a third compression zone at a third depth, wherein asecond gap larger than the first gap is formed between the anchor andthe third compression zone.
 25. A tissue puncture closure deviceaccording to claim 22, further comprising a filament extending throughthe carrier tube, wherein the filament is threaded through the sealingplug and the anchor.
 26. A tissue puncture closure device assemblycomprising: a carrier tube having a distal end and a filament extendingtherethrough; a sealing plug disposed inside the distal end of thecarrier tube and attached to the filament; an anchor attached to thefilament at the distal end of the carrier tube; a multi-level die forcompressing a multi-level nest in the distal end of the carrier tube.27. A tissue puncture closure device assembly according to claim 26wherein the multi-level die comprises a first level and a second level,the second level being higher than the first level.
 28. A tissuepuncture closure device assembly according to claim 27 wherein themulti-level die further comprises a third level, the third level beinglower than the first and second levels.
 29. A method of making a tissuepuncture closure device, comprising: providing a carrier tube; threadinga suture through the carrier tube; threading the suture through asealing plug and an anchor; compressing a multi-level nest into a distalend of the carrier tube.
 30. A method of making a tissue punctureclosure device according to claim 29, further comprising nesting theanchor in the multi-level nest.
 31. A method of making a tissue punctureclosure device according to claim 30 wherein nesting the anchor in themulti-level nest further comprises leaving a gap between a portion ofthe anchor and one level of the multi-level nest.
 32. A method of makinga tissue puncture closure device according to claim 31 whereincompressing comprises engaging a multi-level die with the distal end ofthe carrier tube.
 33. A method of making a tissue puncture closuredevice according to claim 31 wherein the multi-level nest comprises twoor three different levels.
 34. A tissue puncture closure device madeaccording to the method of claim
 29. 35. A method of sealing a tissuepuncture in an internal tissue wall accessible through a percutaneousincision, comprising: providing a tissue puncture closure devicecomprising a carrier tube with a filament extending therethrough, thefilament connected at a distal end of the carrier tube to an anchor, theanchor seated in a multi-level nest disposed in the carrier tube, thefilament also connected to a sealing plug located proximal of the anchorfor disposition and anchoring about the tissue puncture; inserting thetissue puncture closure device into the percutaneous incision; deployingthe anchor into the tissue puncture; withdrawing the closure device fromthe percutaneous incision; tamping the sealing plug toward the anchor.36. A method of sealing a tissue puncture in an internal tissue wallaccessible through a percutaneous incision according to claim 35 whereinthe deploying the anchor further comprises sliding a monofold tip of aninsertion sheath into a gap formed between the anchor and themulti-level nest disposed in the carrier tube.
 37. A method of reducinganchor shuttle in a subcutaneous tissue puncture sealing devicecomprising providing a gap between a carrier tube of the tissue puncturesealing device and the anchor by creating a multi-level nest in thecarrier tube or indenting the anchor.
 38. A method of reducing anchorshuttle in a subcutaneous tissue puncture sealing device according toclaim 37 wherein the anchor initially seats in the multi-level nest. 39.A method of reducing anchor shuttle in a subcutaneous tissue puncturesealing device, comprising providing a gap according to claim 37,further comprising coupling the puncture sealing device to an insertionsheath having a one-way valve allowing the anchor pass therethrough in afirst direction, but not allowing the anchor to pass in seconddirection.
 40. A tissue puncture closure assembly comprising a closuredevice for partial insertion into and sealing of an internal tissue wallpuncture, the closure device comprising: a filament extending from afirst end of the closure device; an anchor for insertion through thetissue wall puncture attached to the filament at the first end of theclosure device; the anchor having a first surface and a first end,wherein the first end comprises an indentation; a sealing plug slidinglyattached to the filament adjacent to the anchor; wherein the anchor isseated in a nest comprising a first nest surface, such that the firstsurface of the anchor bears against the first nest surface, and whereinthe indentation is spaced from the first nest surface to create a gapbetween the first end and the first nest surface.